ES2935409T3 - Stabilization devices for vascular access and procedures for their use - Google Patents

Abstract

A stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location on a patient. The stabilization device includes an engaging surface, a proximal surface, and a base surface. The mating surface is configured to contact an adapter attached to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate fixation of the stabilization device at the target location. The base surface forms a contoured portion configured to contact the target location and a recessed portion configured to move away from the target location. (Automatic translation with Google Translate, without legal value)

Description

DESCRIPTION

Stabilization devices for vascular access and procedures for their use

Cross reference to related requests

Background

The embodiments described herein relate generally to medical devices and more particularly to devices and methods for stabilizing vascular access devices such as intravenous catheters and/or extension sets.

Many medical procedures and/or surgical interventions involve inserting an access device or fluid transfer device into a body part. For example, catheters and/or other lumen-defining devices can be inserted into and/or through vascular structures to access parts of the body or to transfer fluids to or from a patient. In some cases, vascular access devices (VADs), such as peripheral intravenous catheters (PIVs), are inserted into patients (for example, when a patient is hospitalized or during other medical procedures) and are designed and/or or are intended to remain within the patient for an extended period.

VADs typically include a catheter made of a soft bioreactive polymer that is partially placed in the body and attached, at a proximal end (eg, the end outside the body) to a hub, which in turn can provide an interface. to bind any suitable device. After placing the VAD (eg, a PIV catheter or the like) within a patient's vein (or artery), it is often desirable to stabilize and/or secure the VAD with respect to the patient. For example, in some cases, movement of the VAD relative to the patient may result in the catheter becoming undesirably bent, flexed, and/or twisted. In other cases, movement of the VAD (for example, along a long axis of the VAD) may remove a portion of the catheter from the patient's body, which in turn may expose that portion of the catheter to a non-sterile environment. Additionally, moving the VAD back to its original position can flush the potentially contaminated portion of the VAD catheter into the patient, thereby increasing the chances of infection.

Stabilization and/or restraint devices are often used in an effort to minimize movement of a placed or indwelling VAD (eg, PIV catheter). However, some known stabilization and/or restraint devices are complicated and/or time consuming, while others may provide inadequate stabilization. In addition, the shape and/or configuration of some known stabilization and/or restraint devices can adversely affect flow rate through a portion of the VAD and/or the vein (or artery) in which the catheter is disposed.

Therefore, a need exists for improved devices and methods for stabilizing placed vascular access devices.

US2011/282291 A1 discloses a stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and disposed at least partially within a portion of the access device. patient, including the stabilization device: an engaging surface configured to be placed in contact with an adapter attached to a proximal end portion of the access device, and a base surface forming a contoured portion and a recessed portion, the contoured portion configured to contact the target patient location, the recessed portion configured to be offset from the target patient location when the contoured portion contacts the target patient location, the stabilization device configured to lock to the target location of the patient so that (i) the adapter is held in a fixed position with respect to the mating surface and (ii) the access device is stabilized with respect to the target location of the patient.

Summary

Devices and methods for stabilizing in place or permanent vascular access devices such as, for example, intravenous or arterial catheters are described herein and defined in the appended claims. In some embodiments, an apparatus includes a stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and disposed at least partially within a part of the patient. The stabilization device may include an engaging surface, a proximal surface, and a base surface. The mating surface is configured to be placed in contact with an adapter attached to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate attachment of the stabilization device to the target location of the patient. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to move away from the target location when the portion contoured is in contact with the target location. The stabilization device is configured to lock to the target location of the patient such that (1) the adapter is held in a fixed position with respect to the mating surface and (2) the access device is stabilized with respect to the location aim.

Brief description of the drawings

FIGS. 1 and 2 are a rear schematic illustration and a right side schematic illustration, respectively, of a stabilization device according to one embodiment.

FIGS. 3-6 are various views of a stabilization device according to one embodiment.

The FIG. 7 is a top view of the stabilization device of FIG. 3 coupled to a vascular access device.

FIGS. 8 and 9 are a right side perspective view and a top view, respectively, of the stabilization device and the vascular access device of FIG. 7 secured to a target location of a patient.

FIGS. 10-13 are various views of a stabilization device according to one embodiment.

FIGS. 14 and 15 are a left side perspective view and a top view, respectively, of the stabilization device of FIGS. 10-13 coupled to a vascular access device and positioned at a target location on a patient.

The FIG. 16 is a flowchart illustrating a method of using a stabilization device according to one embodiment.

Detailed description

In some embodiments, an apparatus includes a stabilization device configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and disposed at least partially within a part of the patient. The stabilization device may include an engaging surface, a proximal surface, and a base surface. The mating surface is configured to be placed in contact with an adapter attached to a proximal end portion of the access device. The proximal surface forms at least one angle and is configured to facilitate attachment of the stabilization device to the target location of the patient. The base surface forms a contoured portion configured to be placed in contact with the target location and a recessed portion configured to move away from the target location when the contoured portion is in contact with the target location. The stabilization device is configured to lock to the target location of the patient such that (1) the adapter is held in a fixed position with respect to the mating surface and (2) the access device is stabilized with respect to the location aim.

In some embodiments, an apparatus includes a stabilization device configured to stabilize a vascular access device disposed at least partially within a vein of a patient. The stabilization device includes a base surface and an engaging surface. The base surface forms a contoured portion configured to be placed in contact with a target location on the patient and a recessed portion configured to at least partially align with and separate from the patient's vein when the contoured portion is in contact with the target location. The mating surface is configured to be placed in contact with an adapter mated to a proximal end portion of the vascular access device. The mating surface includes a first part and a second part. The first part includes at least one protrusion configured to selectively engage the adapter such that (1) one part of the adapter aligns with and is configured to engage the second part of the mating surface when the first part of the mating surface mating surface is in contact with a distal end portion of the adapter, and (2) the adapter part is misaligned with and separates from the second mating surface part when the first mating surface part is in contact with a proximal end portion of the adapter.

In some embodiments, a method of stabilizing a vascular access device disposed at least partially within a vein of a patient includes coupling a stabilization device to the vascular access device disposed at least partially within the vein of the patient. The stabilization device is positioned at a target location on the patient so that a recessed portion formed by a base surface of the stabilization device aligns with the vein. A first strip of tape is applied to a proximal surface of the stabilization device such that a first end portion and a second end portion of the first strip of tape are each in contact with the patient's target location and are distal to a medial part of the tape. The medial part of the first strip of adhesive tape it is at least partially in contact with the proximal surface of the stabilization device and at least partially in contact with the target location of the patient. A second strip of tape is applied to a part of the stabilization device distal to the proximal surface such that the second strip of tape partially overlaps at least the first end part and the second end part of the first strip of tape .

In some embodiments, a stabilization device has a proximal end portion and a distal end portion and is configured to be secured to a patient's skin. The proximal end portion includes a proximal surface that forms at least one configured angle to facilitate attachment of the stabilization device to the patient's skin. A base surface of the stabilization device forms a contour that is configured to be placed in contact with a patient's skin and defines a recess along the contour configured to be spaced from the patient's skin. The stabilization device is configured to mate with at least one of a cone of a placed vascular access device or an adapter attached to the placed vascular access device to stabilize the placed vascular access device when the stabilization device is secured to the skin. of the patient.

As used in this specification, the singular forms "a", "an" and "the" include plural referents unless the context clearly indicates otherwise. Thus, for example, the term "a member" is intended to mean a single member or a combination of members, "a material" is intended to mean one or more materials or a combination thereof, "a device" is intended to mean a single device or a combination of devices.

As used herein, the terms "about" and "approximately" can be used interchangeably and generally mean plus or minus 10% of the stated value. For example, approximately 0.5 would include 0.45 and 0.55, approximately 10 would include 9 to 11, approximately 1000 would include 900 to 1100.

Similarly, the term "substantially" when used in connection with a geometric construction and/or geometric relationship, is intended to convey that the structure and/or relationship so defined is nominally the recited structure and/or relationship. As an example, a first part of a stabilization device that is described as "substantially perpendicular" to a second part of the stabilization device is intended to convey that, although a perpendicular relationship is desirable (e.g., positioned, arranged in, and/or otherwise forming a 90° orientation or angle), some variation or lack of perpendicularity may occur in a "substantially perpendicular" relationship. As another example, two geometric constructions that are described as substantially aligned are intended to convey that while alignment of the geometric constructions is desirable, some variation or misalignment may occur. In some cases, variations such as those described above may result from, for example, manufacturing tolerances or other practical considerations. Thus, a geometric construction modified by the term "substantially" includes such geometric properties within a tolerance of plus or minus 5% of the established geometric construction. For example, a "substantially perpendicular" relationship is a relationship between two geometric constructions that is within plus or minus 5% of being perpendicular.

As used herein, the term "assembly" can refer to multiple features or a single feature with multiple parts. For example, when referring to a set of protrusions, the set of protrusions can be considered as one protrusion with multiple parts, or the set of protrusions can be considered as multiple distinct protrusions. Thus, a monolithically constructed article may include a set of protrusions. Said "assembly" may include multiple parts and/or components that are either continuous or discontinuous with each other. In addition, an "assembly" can also be formed from multiple components that are produced separately and then joined together (eg, by means of welding, adhesive, or any suitable method).

The devices and procedures described herein are configured to stabilize devices and/or device components that are directly or indirectly inserted into a patient. Such devices are generally referred to herein as vascular access devices (VADs). Non-limiting examples of a VAD may include intravenous (i.v.) access devices such as peripheral intravenous (PIV) catheters, peripheral intravenous central catheters (PICC or PIC lines), midline catheters, extended-dwell catheters (EDCs), etc. . In other embodiments, a VAD may be an intra-arterial access device such as an arterial line and/or the like. Although reference is made herein to use with specific access devices, it is to be understood that such reference is presented by way of example and without limitation.

As used herein, the term "catheter" describes an element configured to define a passageway such as a cannula, tube, or other lumen-defining structure. In some cases, a catheter may be used to move bodily fluid from a first location to a second location (eg, a fluid passageway for removing bodily fluid from the body). Although the cannulas can be configured to receive a trocar, guide needle, or introducer to deliver the cannula to a volume within the body of a patient, the catheters and/or cannulas referred to herein need not include or receive a trocar, guide needle, or introducer and can be positioned and/or inserted, for example, into a patient's vasculature using any procedure appropriate.

As used in this specification, the term "extension set" generally refers to a device or adapter that mates with a hub of a VAD such as an i.v. catheter. peripheral or similar. "Extension sets" can have any suitable configuration. For example, in some embodiments, an extension set may be a single-port or multi-port adapter. As a specific example, an extension set can be and/or can refer to a "Y-shaped" dual-port extension. In other embodiments, an extension assembly can be and/or can refer to a "T-shaped" dual-port extension assembly.

In general, some known extension assemblies are configured to mate between a VAD cone and/or any suitable medical device and may allow one or more objects, devices, medications, fluids, etc. access a part of a patient's body (for example, via the VAD). More particularly, in some cases, an extension assembly can be attached to a permanent access device (eg, a PIV or the like) and can facilitate the transfer and/or collection of one or more fluids. In some cases, the fluid may be a bodily fluid including, but not limited to, blood, cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, mucus, vitreous humor, air, and the like. , or any combination thereof.

In some embodiments, any of the extension sets described herein may be a commercially available extension set. That is, in some embodiments, the stabilization devices described herein can be configured for use with a commercially available extension kit. In other embodiments, any of the stabilization devices described herein can be configured for use with a custom extension set and/or an extension set configured for specific use with the stabilizer devices described herein. . Accordingly, it is to be understood that the term "extension set" is provided by way of example only and without limitation.

As used in this specification, the words "proximal" and "distal" refer to the direction of closest and farthest, respectively, from a user who would place the device in contact with a patient. Thus, for example, the end of a device that first touches the patient's body would be the distal end, while the opposite end of the device (for example, the end of the device that is being manipulated by the user) would be the proximal end of the device. device. Furthermore, the terms "proximal" and "distal" when referring to a position of a construct or the like may be used to describe, for example, a relative position of the construct so described. For example, a first part of a device can be said to be distal to the second part of the device when the position of the first part of the device is further from the user of the device than the position of the second part of the device. device.

FIGS. 1 and 2 are schematic illustrations of a stabilization device 100 according to one embodiment. The stabilization device 100 is configured to be placed in contact with a patient's skin at or near an insertion site of an indwelling or placed vascular access device (VAD) such as those described above. The stabilization device 100 is configured to attach to and/or otherwise engage the VAD and/or a device attached to the VAD. Once attached to the VAD and/or the device attached to the VAD, the stabilization device 100 may be secured to the patient's skin, which in turn secures and/or stabilizes at least a portion of the VAD with respect to the patient, as shown. described in more detail in this document.

Stabilization device 100 may have any suitable shape, size, and/or configuration. As shown in FIGS. 1 and 2, the stabilization device 100 has a proximal end portion 102 and a distal end portion 106, and has a base surface 108 and an engaging surface 112. The proximal end portion 102 has a proximal surface 104 that has a predetermined and/or desired shape. For example, in some embodiments, the proximal surface 104 may be tapered, tapered, flared, curved, rounded, and/or the like. As described in more detail herein, the arrangement and/or shape of the proximal surface 104 may facilitate the attachment or attachment of the stabilization device 100 to the patient's skin (eg, by means of tape or the like).

The base surface 108 can have any suitable shape and/or configuration. For example, the base surface 108 may have a contour and/or be generally concave. In some embodiments, the concave contour and/or shape may be based at least in part on a curvature and/or shape of a part of the patient's anatomy. For example, in some embodiments, the base surface 108 may have a contour and/or shape that is based at least in part on a general contour and/or curvature of a patient's hand or forearm (or other site of contact). suitable iv insertion). In some embodiments, shaping the contour and/or shape of the base surface 108 to be similar to and/or based at least partially on the curvature of a patient iv insertion site can increase, for example, the area of surface of the base surface 108 that it is in contact with the patient's skin, which in turn can increase the stability of the stabilization device 100 when it is secured to the patient's skin, as described in more detail herein.

As shown in FIG. 1, the base surface 108 defines a recess 110 (eg, a notch, indentation, cutout, etc.) that extends along the base surface 108 in the direction of a longitudinal axis of the stabilization device 100. In other words, recess 110 extends along base surface 108 in a proximal-distal direction. In some embodiments, recess 110 extends along base surface 108 through proximal end portion 102 and through distal end portion 106 (for example, along length L of the base surface 108 (FIG. 2)). In some embodiments, when the base surface 108 of the stabilization device 100 is placed in contact with the patient's skin, the recess 110 can be detached from the patient's skin (eg, not in contact with the patient's skin). ). In other embodiments, the base surface 108 including the recess 110 may contact the patient's skin.

The stabilization device 100 is configured to be placed in a position along the patient's skin such that the recess 110 aligns with and/or is otherwise disposed over a vein of the patient. In some cases, the stabilization device 110 may be placed on the patient's skin at or near an insertion site (also called a "target site") of, for example, an i.v. catheter. More specifically, the stabilization device 110 is configured to be positioned on the patient's skin such that the recess 110 is disposed over the vein in which the VAD is disposed (eg, indwelling IV catheter, arterial catheter, or the like). In some cases, such an arrangement can reduce an amount of force exerted by the base surface 108 on the vein, which might otherwise result in reduced flow rate through at least a portion of the vein. For example, in embodiments where the recess 110 separates from the patient's skin, the stabilization device 100 does not (or substantially does not) exert a force on the vein in which the VAD is disposed. In other embodiments (for example, when the recess 110 is in contact with the patient's skin), a force exerted by the recess 110 on the vein in which the VAD is disposed may be less than a force exerted by other parts. of the base surface 108 (eg, portions without recess) on or near an area of the patient surrounding the vein.

The mating surface 112 of the stabilization device 110 may have any suitable shape, size, and/or configuration. In some embodiments, the mating surface 112 may form a contour or shape that is based at least partially on a shape of a vascular access device (VAD) 150 (or a cone thereof) and/or a device coupled to a VAD (for example, an extension assembly or the like). In some embodiments, the mating surface 112 may be configured to contact and/or engage an outer surface of the VAD 150 to form and/or define a friction fit therebetween. That is, mating surface 112 may have a size and/or shape that is slightly smaller than VAD 150 to form a friction fit, pressure fit, interference fit, etc. when VAD 150 is in contact with mating surface 112.

In some embodiments, the shape and/or contour of the engaging surface 112 may be configured to position the VAD 150 at a predetermined, predefined, and/or otherwise desired angle with respect to the patient's skin at or near the VAD insertion site 150. For example, in some embodiments, the engaging surface 112 may be angled such that a height of the engaging surface 112 at 0 near the proximal end portion 102 is greater than a height of the engaging surface 112 at or near the distal end portion 106. In some embodiments, the engaging surface 112 of the stabilization device 100 may be arranged to secure the VAD 150 at any suitable angle based on at least part at an insertion angle of, for example, the VAD 150 or a catheter thereof. For example, in some embodiments, the engaging surface 112 can be configured to position the VAD 150 at an angle that can minimize the risk or likelihood that the VAD 150 (eg, a VAD catheter 150) will become kinked.

As described above, the stabilization device 100 can be used to secure, for example, a device attached to a vascular access device. By way of example, in some embodiments, the stabilization device 100 may be configured to mate with and/or secure an i.v. extension set, which in turn mates with an indwelling or placed intravenous catheter. Although not shown in FIGS.

1 and 2, in such embodiments, the mating surface 112 may have a shape and/or contour that is configured and/or suitable for use with a dual port extension assembly such as a shaped extension assembly. of Y, a T-shaped extension set, and/or the like. For example, in some embodiments, the mating surface 112 may have a side channel or the like configured to receive one of the ports of such an extension assembly (eg, a side port of a T-shaped extension assembly). . In some embodiments, the side channel or the like may be configured to extend substantially perpendicular to the engaging surface 112 and/or the other portions of the engaging surface 112.

As described above, stabilization device 100 is configured to secure and/or stabilize VAD 150 to, for example, a patient's skin. For example, in some cases, an i.v. (for example, the VAD 150) in a patient's hand so that (1) a portion of the i.v. is placed within a vein and (2) a hub of the i.v. is disposed of outside the patient. In some cases, an extension set (eg, T-adapter, Y-adapter, and/or the like) can be attached to the hub of the i.v. catheter. With the extension set attached to the i.v. cone, a user (for example, a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device 100 by placing a portion of the extension set (for example, , depicted in FIGS. similar with the part of the extension set for attaching the extension set to the stabilization device 100. Although the extension set is described above attached to the i.v. prior to attaching to stabilization device 100, in other embodiments, stabilization device 100 may be positioned in a desired position and/or the extension assembly may be attached to stabilization device 100 prior to attaching the extension assembly to the i.v. cone

Once the stabilization device 100 is attached to the extension set, the stabilization device 100 can be positioned on the patient's skin (eg, at or near the insertion site). In this example, the i.v. it is inserted into the patient's hand and thus the stabilization device 100 is positioned with respect to the patient's hand. Thus, the base surface 108 of the stabilization device 100 can be placed in contact with the patient's skin at or near the insertion site (for example, the site where the VAD 150 or i.v. catheter is inserted into the patient). ). In some cases, stabilization device 100 can be adjusted and/or positioned so that recess 110 aligns with and/or is otherwise arranged around or over the vein in which the i.v. catheter is disposed, as shown described above.

Having attached the stabilization device 100 to the extension assembly and having placed the stabilization device 100 in the desired position at or near the insertion site, the user can secure the stabilization device 100 to the patient. In some embodiments, the user can secure the stabilization device 100 by means of tape or the like. For example, a user can remove a strip of tape from a roll of tape (eg, a first strip of tape) and can apply the strip of tape to proximal surface 104 of stabilization device 100 (not shown in FIGS. 1 and 2) such that a first part of the tape adheres to the proximal surface 104 and a second part of the tape adheres to the patient's skin. In some cases, the user can substantially center the tape with respect to the proximal surface 104. As described above, the proximal surface 104 can have a shape, size, and/or configuration that facilitates the attachment of the stabilization device 100. For example In some embodiments, the proximal surface 104 may be sloped and/or may have a relatively curved or similar contour so that when the user applies the tape to the proximal surface 104, the tape curves, bends, conforms and/or otherwise forms a shape and/or follows a path that is based at least partially on the shape of the proximal surface 104. As described in more detail herein, in some embodiments, the arrangement of the proximal surface 104 may be such that the end portions of the tape adhere to the patient's skin and are located distal to the proximal surface 104.

In some cases, the user can remove a second strip of tape (not shown in FIGS. 1 and 2) from the roll of tape and can apply the second strip of tape transversely through a portion of the stabilization device 100 and the VAD. 150. In some cases, the user may apply the second strip of tape so that a first end portion of the tape adheres to a portion of the patient's skin on a first side of the stabilization device 100; a second end portion of the tape is adhered to a portion of the patient's skin on a second side of the stabilization device 100 substantially opposite the first side of the stabilization device 100; and a medial portion (eg, between the first end portion and the second end portion) adheres to at least one of the stabilization device 100 or the VAD 150. In addition, the first end portion of the second strip of tape it may at least partially overlap a first end portion of the first adhesive strip and the second end portion of the second adhesive strip may at least partially overlap a second end portion of the first adhesive strip.

Although it is described that the first tape strip and the second tape strip are applied in a specific order, it is to be understood that the tape strips can be applied to the stabilization device 100 and VAD 150 in any suitable order. For example, in some cases, the user may apply the second strip of tape transversely through the stabilization device portion 100 and VAD 150 (as described above) and then apply the first strip of tape to the proximal surface. 104 of the stabilization device 100 (as described above). Therefore, in such cases, a part of the first adhesive strip overlaps a part of the second adhesive strip.

Securing the stabilization device 100 to the patient's skin (eg, by means of tape) results in the stabilization device 100 and/or tape securing, stabilizing, and/or immobilizing substantially the VAD 150 with respect to the patient. That is, the arrangement of the stabilization device 100 is such that securing the stabilization device 100 and VAD 150 to the patient's skin can substantially reduce and/or prevent movement of the VAD 150 or at least one iv catheter relative to it. to the vein in which the iv catheter is at least partially disposed, as described in more detail herein with respect to a specific embodiment. In addition, the provision of the recess 110 along the base surface 108 can substantially reduce and/or eliminate a force that would otherwise be exerted on the vein in which the VAD 150 is disposed (eg, iv catheter or similar ).

FIGS. 3-9 illustrate a stabilization device 200 according to one embodiment. As described above with reference to stabilization device 100, stabilization device 200 is configured to be placed in contact with a patient's skin at or near an insertion site of an indwelling or placed vascular access device (VAD). The stabilization device 200 is configured to attach to and/or otherwise engage the VAD and/or a device attached to the VAD (eg, an extension assembly). Once attached to the VAD and/or the device attached to the VAD, the stabilization device 200 may be secured to the patient's skin, which in turn secures and/or stabilizes at least a portion of the VAD with respect to the patient, as shown. described in more detail in this document.

Stabilization device 200 may have any suitable shape, size, and/or configuration. For example, in some embodiments, stabilization device 200 may have a size and/or shape that is based, at least in part, on a size and/or shape of the VAD to be stabilized. In some embodiments, the size and/or shape of the stabilization device 200 can facilitate use, for example, by simplifying a procedure of securing the stabilization device 200 to a patient's skin. In some embodiments, the size and/or shape of the stabilization device 200 may increase ergonomics, grip, and/or the like. For example, in some embodiments, stabilization device 200 and/or a portion thereof may allow a user to maintain a secure grip on stabilization device 200 while the user attaches (or undocks) one or more devices to a VAD, an extension set, and/or any other suitable stabilizing device. In some cases, maintaining a secure grip during such a docking or undocking procedure can limit the force exerted on stabilization device 200 that might otherwise be sufficient to move stabilization device 200 relative to a target location on the patient ( for example, an i.v. catheter insertion site). In other words, the size and/or shape of the stabilization device 200 may allow it to substantially stabilize, secure, and/or immobilize a VAD attached to it when the user attaches or detaches a device (for example, a fluid transfer device or similar) to VAD

As shown in FIGS. 3-6, stabilization device 200 has a proximal end portion 202 and a distal end portion 206, and has a base surface 208 and an engaging surface 212. In general, engaging surface 212 is configured to receive , retain, and/or otherwise mate with an extension assembly 260 such as, for example, a T-adapter or a T-connector, which in turn mates with a permanent or in-place VAD. In this embodiment, the indwelling or placed VAD can be, for example, an i.v. catheter. 250 (see, for example, FIGS. 7-9). The base surface 208 is configured to be placed in contact with a patient's skin in a predetermined and/or desired manner at or near an i.v. catheter insertion site. 250 or the like (also referred to herein as "target location"). Once stabilization device 200 is attached to extension assembly 260 and base surface 208 is in contact with the patient's skin at or near the insertion site, stabilization device 200 (and extension assembly 260) may be secured to the patient's skin (see, for example, FIGS. 7 and 8) to secure and/or stabilize at least a portion of the i.v. catheter. 250 with respect to the patient and/or the vein in which the i.v. 250, as described herein below.

The proximal end portion 202 has a proximal surface 204 that has a predetermined and/or desired shape. For example, proximal surface 204 may be tapered, tapered, flared, curved, rounded, and/or the like. In the embodiment shown in FIGS. 3-9, proximal surface 204 may have a rounded, curved, parabolic, and/or substantially flared perimeter. Additionally, proximal end portion 202 and/or proximal surface 204 may include a set of extensions 205 (eg, legs, tabs, pads, nubs, etc.) that extend transversely away from a center of stabilization device 200. As described in more detail herein, the arrangement and/or shape of the proximal surface 204 and/or extensions 205 may facilitate the attachment or attachment of the stabilization device 200 to the patient's skin (for example, by adhesive tape or similar).

The base surface 208 can have any suitable shape and/or configuration. For example, as shown in FIGS. 4 and 5, base surface 208 may have a contour and/or shape that is generally concave. In some embodiments, the concave contour and/or shape may be based at least in part on a curvature and/or shape of a part of the patient's anatomy. For example, in some embodiments, the base surface 208 may have a contour and/or shape that is based at least in part on a general contour and/or curvature of a patient's hand or forearm (or other site of contact). insertion and/or suitable target location). In some embodiments, shaping the contour and/or shape of the base surface 208 to be similar to and/or based at least partially on the curvature of the patient's target location may increase, e.g. For example, the surface area of the base surface 208 that is in contact with the patient's skin, which in turn can increase the stability of the stabilization device 200 when secured to the patient's skin, as further described. detail in this document.

As shown in FIGS. 4 and 5, base surface 208 defines a recess 210 (eg, a notch, indentation, cutout, etc.) that extends along base surface 208 in the direction of a longitudinal centerline of the device. stabilization 200. In other words, recess 210 extends along base surface 208 in a proximal-distal direction. In some embodiments, recess 210 extends along base surface 208 through proximal end portion 202 and through distal end portion 206, as described above with reference to stabilization device 100. shown in FIG. 2. In some embodiments, the recess 210 may have and/or may form a curved cross-sectional shape with a constant or variable radius of curvature. For example, in some embodiments, recess 210 may have and/or may form a parabolic cross-sectional shape. In other embodiments, the recess 210 may have and/or may form any suitable cross-sectional shape such as, for example, a V-shape, a U-shape, a W-shape and/or any other suitable cross-sectional shape. In some embodiments, the size and/or shape of the recess 210 may be substantially constant along the stabilization device 200. In other embodiments, the size and/or shape of the recess 210 may vary along the length of the stabilization device 200. length of stabilization device 200. For example, in some embodiments, recess 210 may be tapered, decreasing in size and/or shape from a first size at the proximal end portion 202 to a second size at the proximal end portion 202. distal 206 (or vice versa).

The stabilization device 200 is configured to be placed in a position along the patient's skin such that the recess 210 aligns with and/or is otherwise disposed over the vein in which the i.v. catheter is disposed. 250. In some embodiments, when the base surface 208 of the stabilization device 200 is placed in contact with the patient's skin, the recess 210 can be detached from the patient's skin (eg, not in contact with the patient's skin). of the patient). In other embodiments, the base surface 208 including the recess 210 may contact a portion of the patient's skin. In some embodiments, the recess 210 may have a height (or depth) and a width that are each greater than a diameter of the vein in which the i.v. catheter is to be placed. 250. In other words, a size and/or shape of the recess 210 may be based at least in part on a size and/or shape of a vein over which the stabilization device 200 is disposed. For example, in some modes of In one embodiment, the recess 210 can have a height or depth that is from about 0.5 millimeters (mm) to about 3.0 mm and a width that is from about 5.0 mm to about 40.0 mm. As an example, a recess 210 may have a height or depth that is approximately 2.0mm and a width that is approximately 20mm.

Although recess 210 is shown in particular, for example, in FIGS. 4 and 5, in some embodiments, recess 210 may be of any suitable size and/or shape. In some embodiments, the size and/or shape of the recess 210 may take into account variations in size, shape, and/or path of the vein. For example, in some cases, a vein in which the i.v. 250 may have one or more branch vessels attached thereto, may extend in a non-linear or curved path, may extend at an angle, and/or may otherwise vary in size, shape, and/or arrangement between patients. As such, recess 210 may have a width that is large enough to allow recess 210 to be arranged over a vein that may vary in size, shape, and/or arrangement. In some embodiments, for example, the recess 210 may have a width that is slightly less than a width of the base surface 208. In such embodiments, a relatively thin portion of the base surface 208 may be arranged in opposite sides of recess 210. In other embodiments, base surface 208 may include two bumps, ridges, ridges, rails, etc. parallel or substantially parallel that together define a space between them. In said embodiments, the part of the base surface 208 arranged between the two protrusions or the like may form and/or function similar to the recess 210.

In some embodiments, forming and/or defining the recess 210 to be larger (eg, in height and/or width) than the vein in which the i.v. catheter is disposed. 250, for example, can reduce an amount of force that would otherwise be exerted by the base surface 208 on the vein. In some cases, such force exerted by the base surface 208 on the vein may be sufficient to reduce blood flow within the vein. In some specific cases, such a reduction in flow may adversely affect the ability to draw blood from the vein and/or may prevent the delivery of fluids to the vein. Consequently, the formation of the recess 210 in the base surface 208 is such that the stabilization device 200 does not (or substantially does not) exert a force on the vein in which the i.v. catheter is disposed. 250, thereby allowing stabilization device 200 to secure and stabilize the i.v. catheter. 250 without substantially impeding a flow of fluid through the vein.

Although recess 210 is described above as being configured to substantially reduce and/or remove a force exerted on the vein in which iv catheter 250 is disposed, in some embodiments, recess 210 may allow movement and/or reconfiguration of a portion of the patient while continuing to provide stabilization to or for the iv catheter 250. For example, in some embodiments, an iv catheter (eg, iv catheter 250) may be inserted into a patient's cephalic or basilic vein and can secure a stabilization device 200 (eg, stabilization device 200) to the antecubital fossa region of the patient. In some cases, bending the patient's arm (for example, at the elbow) may result in a change in the tension, stress and/or stretching of the skin in both the circumferential and axial directions along the patient's arm. . In some cases, such a change in tension or the like may result in a bunching or bulging of the skin in or near the antecubital fossa region. In some cases, such bunching or bulging of the skin can result in unwanted lifting or movement of a stabilization device relative to an iv insertion site, which in turn can result in movement, bending, twisting , etc. unwanted iv catheter disposed in vein.

In some embodiments, however, the arrangement of the recess 210 of the stabilization device 200 may allow at least a portion of the skin to bunch or bulge into a space defined by the recess 210, thereby at least partially filling the skin. the void of recess 210, and substantially reducing and/or preventing unwanted lifting or movement of stabilization device 200. In other words, in some cases, the arrangement of stabilization device 200 may be such that stabilization device 200 stabilizes , secures and/or substantially immobilizes the i.v. 250 despite at least some patient movement. Furthermore, in some embodiments, the recess 210 may extend across the width of the stabilization device 200 such that only the edges of the base surface 208 and/or only the protrusions extending from the base surface 208 are in contact with the skin. In such embodiments, this arrangement may allow the skin to shift and stretch axially under and to either side of the stabilization device 200 as shear forces are applied from skin movement, thereby reducing the amount of force that would otherwise result in lateral movement of the stabilization device 200 with respect to the insertion site and/or target location.

The mating surface 212 of the stabilization device 210 may have any suitable shape, size, and/or configuration. In the embodiment shown in FIGS. 3-9, mating surface 212 may form a contour or shape that is based at least partially on a shape of extension assembly 260. In some embodiments, mating surface 212 may be configured to contact and/or or engage an outer surface of extension assembly 260 to form and/or define a friction fit therebetween. That is, mating surface 212 may have a size and/or shape that is slightly smaller than extension assembly 260 to form a friction fit, pressure fit, interference fit, etc. when extension assembly 260 is in contact with mating surface 212.

In the embodiment shown in FIGS. 3-9, mating surface 212 may be configured to receive and/or mate with a T-shaped connector or adapter (eg, extension assembly 260). For example, mating surface 212 includes a distal notch 214 and one or more lateral channels 216. Distal notch 214 formed by and/or along mating surface 212 may be configured to accommodate a distal locking mechanism 262 ( eg, Luer-Lok®) of extension assembly 260. For example, in some embodiments, extension assembly 260 (eg, T-adapter) may include a twist lock on a distal end portion thereof which is configured to physically and fluidically couple the extension assembly 260 to the i.v. catheter. 250. Accordingly, the distal notch 214 can provide sufficient clearance for a user to grasp and rotate the twist lock to engage or disengage the distal locking mechanism 262 of the extension set 260 to or from the i.v. catheter. 250. Additionally, extension assembly 260 can be engaged with mating surface 212 so that a proximal locking mechanism 261 of extension assembly 260 is proximal to proximal surface 204 of stabilization device 200, as shown in Figure FIG. 7. In some embodiments, such an arrangement may facilitate the engagement or disengagement of one or more devices (eg, fluid transfer device, syringe, fluid reservoir, etc.) to or from the locking mechanism. proximal 261 of the extension assembly 260.

The one or more side channels 216 of the stabilization device 200 may have any suitable shape, size, and/or configuration. In the embodiment shown in FIGS. 3-9, stabilization device 200 includes two side channels 216, with one side channel 216 on opposite sides of stabilization device 200 and extending in a direction perpendicular and/or transverse to, for example, a center line. longitudinal C of the stabilization device 200 (see, for example, FIG. 6). At least one of the side channels 216 is configured to receive a side port 263 of the extension assembly 260 (see, for example, FIG. 7). For example, in the embodiment shown in FIGS. 3-9, extension assembly 260 is a dual port extension assembly having a "T" configuration in which lateral port 263 is substantially perpendicular to a longitudinal axis A defined between proximal locking mechanism 261 and the distal locking mechanism 262 (see, eg, FIG. 7). Consequently, when extension assembly 260 engages mating surface 212, the longitudinal centerline C of stabilization device 200 and the longitudinal axis A defined by extension assembly 260 align and/or are substantially coaxial and the Side port 263 of extension assembly 260 may be placed in contact with, disposed of, and/or extended through side channel 216 on a left side of stabilization device 200 or on a right side of stabilization device 200.

In some embodiments, the arrangement of the mating surface 212 and the extension assembly 260 may be such that the extension assembly 260 is placed in contact with the mating surface 212 and rotated to a position in which the port lateral 263 is arranged in one of the lateral channels 216. In some embodiments, a part of the mating surface 212 that forms and/or defines the lateral channels 212 may form a snap or snap fit with at least one part of the side port 263 of the extension assembly 260. Also, in use, the side port 263 of the extension assembly 260 typically mates with a flexible tube 265 (see, for example, FIG. 7) or the like and, as such, The side channels 216 can be configured to allow the coupling of the flexible tube 265 to the side port 263 of the extension assembly 260 without resulting in undue bending or kinking of the flexible tube 265.

In some embodiments, the shape and/or contour of the engaging surface 212 may be configured to position and/or maintain a VAD (eg, i.v. catheter 250) at a predetermined, predefined, and/or other angle. desired relative to the patient's skin at or near the i.v. catheter insertion site. 250 (or target location). For example, in some embodiments, mating surface 212 may be angled such that a height of mating surface 212 at or near proximal end portion 202 is greater than a height of mating surface 212 at or near distal end portion 206. In some embodiments, engaging surface 212 may be configured to receive, engage, and/or secure the i.v. catheter. 250 at an angle between, for example, about 3° to about 15° to the patient's skin at the insertion site. Specifically, in some embodiments, the mating surface 212 may be configured to receive, engage, and/or secure the i.v. catheter. 250 at an angle of about 10°, about 8°, about 6° or less. In some embodiments, the engagement surface 212 of the stabilization device 200 may be arranged to secure the i.v. catheter. 250 at any suitable angle based at least in part on an angle of insertion of, for example, the i.v. For example, in some embodiments, the mating surface 212 may be configured to position and/or maintain the i.v. catheter. 250 at an angle that can minimize the risk or likelihood that the i.v. 250 is twisted (for example, at the skin entry or the IV catheter insertion site).

In some embodiments, the stabilization device 200 may be configured to secure the i.v. catheter. 250 at an angle that relies at least in part on an i.v. insertion site. For example, in some embodiments, a stabilization device may be configured to secure an i.v. catheter. at a first angle when the i.v. is inserted, for example, in the antecubital fossa and a second angle, different from the first angle, when the i.v. it is inserted, for example, in the hand. In such embodiments, stabilization device 200 may include an indicator and/or may have a color or the like configured to provide an indication to a user associated with the intended use or intended insertion site.

As shown in FIGS. 7-9, stabilization device 200 is configured to secure and/or stabilize the i.v. catheter. 250 with respect to, for example, a target location of a patient. For example, in some cases, the i.v. 250 may be inserted into a patient's hand (eg, at or along a target location) such that (1) a portion of the i.v. 250 is disposed within a vein (insertion of i.v. catheter 250 not shown in FIGS. 7-9) and (2) a hub of i.v. 250 is disposed of outside the patient. In some cases, the extension assembly 260 (eg, the T-adapter) may be physically and fluidically coupled to the hub of the i.v. catheter. 250.

With the extension assembly 260 attached to the i.v. cone, a user (eg, a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device 200 by placing a portion of the extension assembly 260 in contact with the mating surface 212 of the stabilization device 200. As described above, the mating surface 212 may be configured to form a friction fit and/or the like with the extension assembly portion 260 to engage the extension assembly 260 to stabilization device 200. As shown, for example, in FIG. 7, extension assembly 260 may be engaged with mating surface 212 of stabilization device 200 such that distal locking mechanism 262 or the like of extension assembly 260 is at least partially arranged and/or otherwise aligned. with distal notch 214. As described above, such an arrangement may allow the user to engage distal locking mechanism 262 to engage extension assembly 260 or disengage extension assembly 260 from the i.v. catheter. 250. In addition, the side port 263 of the extension assembly 260 is positioned within one of the side channels 216 (see, for example, FIG. 7) so that the flexible tube 265 attached to the side port 263 can be extended out. of the side channel 216. Accordingly, the side port 263 of the extension assembly 260 can be used to supply or withdraw fluid from the vein in which the i.v. catheter is disposed. 250. In addition, the proximal port or locking mechanism 261 of the extension assembly 260 may be disposed in a proximal position with respect to the proximal surface 204 when the extension assembly 260 engages the mating surface 212. In this manner, Any suitable device may be attached to the proximal port or locking mechanism 261 to deliver fluids to, withdraw fluids from, and/or otherwise access the vein in which the i.v. catheter is disposed. 250.

Once stabilization device 200 is attached to extension assembly 260, stabilization device 200 can be positioned on the patient's skin (eg, at or near the insertion site or target location). In this example, the 250 iv catheter is inserted into the patient's hand and thus the device stabilization device 200 is positioned relative to the patient's hand. Thus, the base surface 208 of the stabilization device 200 can be placed in contact with the patient's skin at or near the iv catheter 250 insertion site and/or otherwise at or near a target location on the patient. As described above, the stabilization device 200 can be adjusted and/or positioned so that the recess 210 aligns with and/or is otherwise arranged around or over the vein in which the iv catheter 250 is disposed. In this manner, securing the stabilization device 200 to the patient's skin does not result in the base surface 208 exerting a force on the vein that might otherwise be sufficient to occlude and/or restrict flow through the vein. come to.

Having attached the stabilization device 200 to the extension assembly 260 and having placed the stabilization device 200 in the desired position at or near the insertion site (for example, so that the recess 210 aligns with or lies over the vein in which the i.v. catheter 250 is disposed), the user can secure the stabilization device 200 to the patient. In some embodiments, the user may secure the stabilization device 200 by means of tape or the like, as shown, for example, in FIGS. 8 and 9. More particularly, in some cases, a user can remove a first strip of tape 232 from a roll of tape and can apply the first strip of tape 232 to the proximal surface 204 of the stabilization device 200 so that a a first part of the tape is adhered to the proximal surface 204 and a second part of the tape is adhered to the patient's skin. For example, in some cases, the user may position the first strip of the tape 232 so that a first portion of the width of the first strip 232 overlaps and/or adheres to the proximal surface 204 of the stabilization device 200 while a second part of the width of the first strip 232 overlaps and/or adheres to the patient's skin, as shown in FIGS. 8 and 9.

As described above, proximal surface 204 may have a shape, size, and/or configuration that facilitates gripping of stabilization device 200. For example, in some embodiments, proximal surface 204 may be tilted and/or may have a relatively curved contour or the like such that when the user applies the first strip of tape 232 to the proximal surface 204, the tape curves, bends, conforms, and/or otherwise forms a shape and/or follows a path which is based at least partially on the shape of the proximal surface 204. As shown in ^FIGS . 8 and 9, the shape and/or configuration of the proximal surface 204 is such that a portion of the first strip of tape is overlaps and/or adheres to the extensions 205. Furthermore, the arrangement of the proximal surface 204 and/or the extensions 205 is such that the first strip of tape 232 is curved and/or bent so that the end portions of the first you ra 232 are adhered to the patient's skin and are positioned distal to, for example, a medial or central portion of the first strip 232, as indicated by arrows AA in FIGS. 8 and 9.

After securing the first strip of tape 232, the user can remove a second strip of tape 234 from the roll of tape and can apply the second strip of tape 234 transversely through a portion of the stabilization device 200 and the i.v. catheter. 250, as indicated by arrows BB in FIGS. 8 and 9. As shown, the user may apply the second tape strip 234 so that a first end portion of the second tape strip 234 adheres to a portion of the patient's skin on a first side of the delivery device. stabilization 200; a second end portion of the second tape strip 234 is adhered to a portion of the patient's skin on a second side of the stabilization device 200 substantially opposite the first side of the stabilization device 200; and a medial or central part (eg, between the first end part and the second end part) is attached to at least one of the stabilization device 200 or the i.v. catheter. 250. In addition, the first end portion of the second tape strip 234 may at least partially overlap a first end portion of the first tape strip 232 and the second end portion of the second tape strip 234 may overlap at least partially overlapping a second end portion of the first tape strip 232, as shown in FIGS. 8 and 9. In some embodiments, placing a portion of the second tape strip 234 over a portion of the first tape strip 232 may enhance adhesion of at least one of the first strip 232 or the second strip 234. In In other words, positioning a portion of the second adhesive strip 234 over a portion of the first adhesive strip 232 can reduce a likelihood that the first adhesive strip portion 232 will become loose, disengage, and/or otherwise seize. break the adhesive bond.

As described above, securing stabilization device 200 to the patient's skin (for example, by means of tape strips 232 and 234) results in stabilization device 200 and/or tape securing, stabilizing, and/or or substantially immobilize the iv catheter 250 with respect to the patient. That is, the arrangement of the stabilization device 200 is such that securing the stabilization device 200 and the iv catheter 250 to the patient's skin can substantially reduce and/or prevent movement of the iv catheter 250 or at least one iv catheter thereof. with respect to the vein in which the iv catheter is at least partially disposed, as described in more detail herein with respect to a specific embodiment. Furthermore, the arrangement of the recess 210 along the base surface 208 is such that securing and/or adhering the stabilization device 200 to the patient's skin does not exert a force on the vein in which the iv catheter 250 is disposed. thereby substantially reducing and/or eliminating any obstruction and/or restriction that would otherwise result from said force.

While the stabilization device 200 is described above with reference to FIGS. 7-9 as secured to a patient's skin by means of, for example, two tape strips, it is to be understood that the stabilization device 200 may be secured to the patient's skin in any suitable manner. For example, although not shown, in some embodiments, the stabilization device 200 may be secured to the skin by means of a transparent dressing or the like, such as, for example, Tegaderm™ and/or the like. In such cases, the transparent dressing may include an adhesive or the like disposed around the perimeter of the dressing or along one or more edges of the dressing. In some embodiments, the transparent dressing may be sized and/or shaped for use with stabilization device 200. For example, the transparent bandage may be sized or shaped to allow the dressing to cover at least the insertion site. i.v. while allowing access, for example, to a proximal port of the extension set 260 or the i.v. catheter. 250 (eg, similar to the tape shown in FIGS. 8 and 9). In some cases, multiple procedures may be used to secure the stabilization device 200 to the skin such as, for example, a combination of transparent dressing and tape, and/or any other suitable fastening procedure (such as an adhesive or the like). .

FIGS. 10-15 illustrate a stabilization device 300 according to one embodiment. As described above with reference to stabilization devices 100 and/or 200, stabilization device 300 is configured to be placed in contact with a patient's skin at or near a vascular access device (VAD) insertion site. ) permanent or placed. The stabilization device 300 is configured to mate with and/or otherwise engage the VAD and/or a device or adapter attached to the VAD (eg, an extension assembly). Once attached to the VAD and/or the device or adapter attached to the VAD, the stabilization device 300 can be secured to the patient's skin, which in turn secures and/or stabilizes at least a portion of the VAD with respect to the patient, as described in more detail herein.

Stabilization device 300 may have any suitable shape, size, and/or configuration. For example, in some embodiments, stabilization device 300 may have a size and/or shape that is based, at least in part, on a size and/or shape of the VAD to be stabilized. In some embodiments, the size and/or shape of the stabilization device 300 may facilitate use, for example, by simplifying a procedure of securing the stabilization device 300 to the VAD, the device or adapter attached to the VAD, and/or the skin of a patient. In some embodiments, the size and/or shape of the stabilization device 300 may increase ergonomics, grip, and/or the like. For example, in some embodiments, the stabilization device 300 and/or a portion thereof may allow a user to maintain a secure grip on the stabilization device 300 while the user attaches (or undocks) one or more devices to a VAD, an extension assembly, and/or any other suitable device being stabilized, as described above with reference to stabilization device 200. In some embodiments, aspects and/or parts of stabilization device 300 may be substantially similar to the corresponding aspects and/or parts of the stabilization device 200. Accordingly, said aspects and/or parts of the stabilization device 300 are not described in further detail herein.

As shown in FIGS. 10-13, stabilization device 300 has a proximal end portion 302 and a distal end portion 306, and has a base surface 308 and an engaging surface 312. In general, engaging surface 312 is configured to receive , retain, and/or otherwise attach to an extension assembly 360 such as, for example, a T-adapter or T-connector, which in turn attaches to an indwelling or in-place VAD, as described above with reference to the mating surface 212 of the stabilization device 200. In this embodiment, the indwelling or placed VAD can be, for example, an i.v. catheter. 350 (see, for example, FIGS. 14 and 15). The base surface 308 is configured to be placed in contact with a patient's skin in a predetermined and/or desired manner at or near an i.v. catheter insertion site. 350 or the like (also referred to herein as "target location"). Once stabilization device 300 is attached to extension assembly 360 and base surface 308 is in contact with the patient's skin at or near the insertion site, stabilization device 300 (and extension assembly 360) may be secured to the patient's skin to secure and/or stabilize at least a portion of the i.v. catheter. 350 with respect to the patient and/or the vein in which the i.v. 350, as described above with reference to stabilization device 200.

The proximal end portion 302 has a proximal surface 304 that has a predetermined and/or desired shape. For example, proximal surface 304 may be tapered, tapered, flared, curved, rounded, and/or the like (see, eg, FIGS. 10-12). In some embodiments, proximal surface 304 may have a rounded, curved, parabolic, and/or substantially flared perimeter (see, for example, FIG. 13). In addition, proximal end portion 302 and/or proximal surface 304 may include a set of extensions 305 (eg, legs, tabs, pads, nubs, etc.) that extend transversely away from a center of stabilization device 300. In some embodiments, the arrangement and/or shape of the proximal surface 304 and/or the extensions 305 may facilitate the attachment or fastening of the stabilization device 300 to the patient's skin (for example, by means of tape or the like). ), as described in detail above with reference to the stabilization device 200.

The base surface 308 can have any suitable shape and/or configuration. For example, as shown in FIGS. 12 and 13, the base surface 308 may have a contour and/or shape that is generally concave. In some embodiments, the concave contour and/or shape may be based at least in part on a curvature and/or shape of a part of the patient's anatomy. For example, in some embodiments, base surface 308 may have a contour and/or shape that is based at least in part on a general contour and/or curvature of a target location and/or i.v. insertion site. of a patient. For example, as described above with reference to the base surface 208 of the stabilization device 200, in some embodiments, the contour and/or curvature may be based on a shape and/or curve of the hand or forearm of a patient (or other suitable insertion site and/or target location).

As shown in FIG. 13, the base surface 308 defines a recess 310 (eg, a notch, indentation, cutout, etc.) that extends along the base surface 308 in the direction of a longitudinal centerline of the stabilization device 300. In other words, recess 310 extends along base surface 308 in a proximal-distal direction. In some embodiments, recess 310 extends along base surface 308 through proximal end portion 302 and through distal end portion 306, as described above with reference to stabilization devices. 100 and/or 200. In some embodiments, base surface 308 and recess 310 may be similar to and/or substantially the same as base surface 208 and recess 210, respectively, of stabilization device 200. Consequently , the size, shape, configuration, and/or shape of the base surface 308 and/or recess 310 are not further described herein.

As described above with reference to stabilization device 200, stabilization device 300 is configured to be placed in a position at or over a target location (for example, along the patient's skin at or near an insertion site). i.v.) such that the recess 310 aligns with and/or is otherwise disposed over the vein in which the i.v. catheter is disposed. 350. In some embodiments, when the base surface 308 of the stabilization device 300 is placed in contact with the patient's skin, the recess 310 can be detached from the patient's skin (eg, not in contact with the patient's skin). of the patient). In some embodiments, the recess 310 may have a height (or depth) and a width that are each greater than a diameter of the vein in which the i.v. catheter is to be placed. 350. In other words, a size and/or shape of recess 310 may be based at least in part on a size and/or shape of a vein over which stabilization device 300 is disposed. As such, recess 310 may having a height and/or width that is large enough to allow the recess 310 to be disposed over and/or above or around a vein that may vary in size, shape, and/or arrangement. Furthermore, forming and/or defining the recess 310 to be larger (eg, in height and/or width) than the vein in which the i.v. catheter is disposed. 350, for example, may reduce an amount of force that would otherwise be exerted by the base surface 308 on the vein and/or may allow movement and/or reconfiguration of a part of the patient while continuing to provide stabilization to or for the catheter. i.v.

350, as described in detail above with reference to stabilization device 200.

The mating surface 312 of the stabilization device 310 may have any suitable shape, size, and/or configuration. In the embodiment shown in ^FIGS . 10-15, the mating surface 312 may form a contour or shape that is based at least partially on a shape of the extension assembly 360. In some embodiments, the mating surface 312 may be configured to contact and/or or engage an outer surface of the extension assembly 360 to form and/or define a friction fit therebetween. That is, at least a portion of the mating surface 312 may be slightly smaller in size and/or shape relative to a corresponding portion of the extension assembly 360 to form a friction fit, press fit, interference fit, etc when the extension assembly 360 is in contact with the mating surface 312.

In some embodiments, mating surface 312 may be configured to receive and/or mate with a T-shaped connector or adapter (eg, extension assembly 360), which in turn mates with a VAD ( for example, the 350 iv catheter). As such, the stabilization device 300 can be configured to stabilize, support, and/or secure the VAD or IV catheter 350 when the mating surface 312 is placed in contact with the adapter, connector, and/or T-shaped extension assembly. 360. In some embodiments, the shape and/or contour of the engaging surface 312 may be configured to position and/or maintain a VAD (eg, iv catheter 350) at a predetermined, predefined, and/or another desired mode with respect to the patient's skin at or near the 350 iv catheter insertion site (or target location). For example, in some embodiments, mating surface 312 may be angled such that a height of mating surface 312 at or near proximal end portion 302 is greater than a height of mating surface 312 at or near the distal end portion 306. In some embodiments, the engaging surface 312 may be configured to receive, engage, and/or secure the iv catheter 350 at an angle between, for example, about 3° to about 15°. ° with respect to the patient's skin at or near the insertion site. In some embodiments, the engaging surface 312 of the stabilization device 300 may be arranged to secure the iv catheter 350 at any suitable angle based at least in part on an insertion angle of, for example, the iv catheter 350 and /or the patient's insertion site, as described in detail above with reference to stabilization device 200.

As shown, for example, in FIG. 12, the mating surface 312 includes a distal notch 314, one or more side channels 316, and one or more protrusions 318. The distal notch 314 formed by and/or along the mating surface 312 may be configured to accommodate a mechanism distal lock 362 (eg, Luer-Lok®) of extension assembly 360. For example, in some embodiments, extension assembly 360 (eg, T-adaptor) may include a twist lock on one portion distal end thereof which is configured to physically and fluidically couple the extension assembly 360 to the i.v. catheter. 350. Accordingly, the distal notch 314 can provide sufficient clearance for a user to grasp and rotate the twist lock to engage or disengage the distal locking mechanism 362 from the extension assembly 360 to or from the i.v. catheter. 350, as described above with reference to the coupling socket 212 of the stabilization device 200.

The one or more side channels 316 of the stabilization device 300 may have any suitable shape, size, and/or configuration. In the embodiment shown in FIGS. 10-15, stabilization device 300 includes two side channels 316, with one side channel 316 on opposite sides of stabilization device 300 and extending in a direction perpendicular and/or transverse to, for example, a center line. longitudinal C of the stabilization device 300 (see, for example, FIG. 12). At least one of the side channels 316 is configured to receive a side port 363 from the extension assembly 360. For example, as shown in FIGS. 14 and 15, extension assembly 360 may be a dual-port extension assembly having a "T" configuration in which lateral port 363 is substantially perpendicular to a longitudinal axis A defined between proximal locking mechanism 361 and distal locking mechanism 362 (see, for example, FIG. 15). Consequently, when extension assembly 360 engages mating surface 312, the longitudinal centerline C of stabilization device 300 and the longitudinal axis A defined by extension assembly 360 align and/or are substantially coaxial and the Side port 363 of extension assembly 360 may be placed in contact with, disposed of, and/or extended through side channel 316 on a left side of stabilization device 300 or on a right side of stabilization device 300.

In some embodiments, the arrangement of the mating surface 312 and the extension assembly 360 may be such that the extension assembly 360 is placed in contact with the mating surface 312 and rotated to a position in which the port lateral 363 is arranged in one of the lateral channels 316. In some embodiments, a part of the mating surface 312 that forms and/or defines the lateral channels 312 may form a snap or snap fit with at least one part of the side port 363 of the extension assembly 360. Also, in use, the side port 363 of the extension assembly 360 is typically coupled to a flexible tube 365 (see, for example, FIGS. 14 and 15) or the like and, as As such, the side channels 316 can be configured to allow the coupling of the flexible tube 365 to the side port 363 of the extension assembly 360 without resulting in undue bending or kinking of the flexible tube 365.

In some embodiments, the one or more protrusions 318 on the mating surface 312 may be arranged and/or configured to ensure that the stabilization device 300 is in a desired orientation and/or is oriented in a desired direction when the surface coupling 312 is placed in contact with extension assembly 360. For example, as shown in FIG. 12, the mating surface 312 can include a set of protrusions 318 that extend from a portion of the mating surface 312 that is distal to the side channels 316. The set of protrusions 318 can have any suitable configuration and/or arrangement. For example, while the mating surface 312 is shown including a set of three protrusions 318, in other embodiments, the mating surface 312 may include any number of protrusions 318 (eg, one protrusion, two protrusions, four protrusions). , five bumps or more). In some embodiments, the protrusions 318 may be substantially uniform or may have one or more heights, widths, lengths, etc.

In some embodiments, protrusions 318 may be configured to selectively engage a portion of extension assembly 360 so that engaging surface 312 is positioned in a desired position and/or orientation relative to extension assembly 360. For example In some embodiments, the arrangement of the protrusions 318 may be such that when the distal end portion 306 of the stabilization device 300 aligns with or contacts the distal locking mechanism 362, the side port 363 of the extension assembly 360 aligns with lateral channels 316. More specifically, when mating surface 312 is placed in contact with extension assembly 360 such that a portion of distal locking mechanism 362 engages and/or aligns with distal notch 314 defined by mating surface 312, side port 363 of extension assembly 360 aligns with and can be arranged in a or side channels 316, as shown in FIGS. 14 and 15. In other words, when the distal end portion 306 of the stabilization device 300 and the distal locking mechanism 362 are positioned in the same orientation (for example, when the stabilization device 300 and extension assembly 360 are oriented in the same direction), the lateral port 363 of the extension assembly 360 can be located in one of the lateral channels 316. In other words, when the distal locking mechanism 362 is disposed in and/or aligned with the notch distal 314 defined by the mating surface 312, a position of the lateral port 363 along the longitudinal axis A of the extension assembly 360 substantially aligns with a position of the lateral channels 316 along the longitudinal center line C of the stabilization device 300, thereby allowing the side port 363 to be disposed in one of the side channels 316.

As described above, the arrangement of protrusions 318 may allow and/or be configured to allow engaging surface 312 to contact and/or engage extension assembly 360 when stabilization device 300 is in a desired orientation with respect to the extension assembly. Conversely, the arrangement of the protrusions 318 may be such that if the stabilization device 300 is placed in an undesired orientation with respect to the extension assembly 360, contact between the mating surface 312 and the extension assembly 360 is can limit and/or a link between them can be limited and/or avoided. For example, in cases where the distal end portion 306 of the stabilization device 300 and the distal locking mechanism 362 do not align, the protrusions 318 can selectively engage a portion of the extension assembly 360, which in turn results in side port 363, of extension assembly 360 being misaligned with respect to side channels 316.

In some embodiments, misalignment between side port 363 and side channels 316 may limit and/or substantially prevent mating surface 312 from contacting and/or mating extension assembly 360, which may provide an indication to a user that the stabilization device 300 is in an undesired orientation with respect to the extension assembly 360 (and/or vice versa). For example, in some cases, protrusions 318 can selectively engage a portion of extension assembly 360 to misalign side port 363 with respect to side channels 316 when stabilization device 300 and extension assembly 360 are positioned in y directions. / or opposite orientations. More particularly, protrusions 318 may selectively engage a portion of extension assembly 360 to misalign side port 363 with respect to side channels 316 when engaging surface 312 of stabilization device 300 is placed at least partially in contact with the extension assembly 360, such that the proximal locking mechanism 361 of the extension assembly 360 aligns with and/or is at least partially disposed in the distal notch 314 defined by the mating surface 312. In other words, when the proximal locking mechanism 361 of extension assembly 360 is disposed in and/or aligned with distal notch 314 defined by mating surface 312, a position of lateral port 363 along longitudinal axis A of extension assembly 360 is misaligned with respect to a position of the side channels 316 along the longitudinal center line C of the stabilization device 30 0, which in turn can limit and/or substantially prevent side port 363 from being arranged in one of side channels 316. Simply put, in some embodiments, protrusions 318 can limit and/or substantially prevent device stabilization device 300 is placed in a desired contact with or engages extension assembly 360 while stabilization device 300 is in a rearward orientation relative to extension assembly 360.

As described above with reference to stabilization device 200, stabilization device 300 is configured to secure and/or stabilize the i.v. catheter. 350 with respect to, for example, a target location of a patient. For example, in some cases, the i.v. 350 may be inserted into a patient's hand (eg, at or along a target location) such that (1) a portion of the i.v. 350 is disposed within a vein and (2) a hub of the i.v. 350 is disposed outside of the patient. In some cases, the extension assembly 360 (eg, the T-adapter) can be physically and fluidically attached to the hub of the i.v. catheter. 350.

With the extension assembly 360 attached to the i.v. cone, a user (eg, a doctor, nurse, technician, physician, surgeon, and/or other medical professional) can manipulate the stabilization device 300 by placing a portion of the extension assembly 360 in contact with the mating surface 312 of the stabilization device 300. As described above, the mating surface 312 may be configured to form a friction fit and/or the like with the extension assembly portion 360 for mating the extension assembly 360 to stabilization device 300. In addition, the arrangement of protrusions 318 can be configured to selectively engage extension assembly 360 so that a user can visually inspect whether stabilization device 300 and extension assembly 360 are positioned in one place. desired orientation relative to each other, as described in detail above. Accordingly, stabilization device 300 can be placed in contact with and/or attached to extension assembly 360 as described in detail above and shown, for example, in FIGS. 14 and 15.

Once stabilization device 300 is attached to extension assembly 360, stabilization device 300 can be positioned on the patient's skin (eg, at or near the insertion site or target location). In this example, the iv catheter 350 is inserted into the patient's hand and thus the stabilization device 300 is positioned with respect to the patient's hand. Thus, the base surface 308 of the stabilization device 300 can be placed in contact with the patient's skin at or near the iv catheter 350 insertion site and/or otherwise at or near a target location on the patient. As described above, the stabilization device 300 can be adjusted and/or positioned so that the recess 310 aligns with and/or is otherwise arranged around or over the vein in which the iv catheter 350 is disposed. In this manner, securing the stabilization device 300 to the patient's skin does not result in the base surface 308 exerts a force on the vein that might otherwise be sufficient to occlude and/or restrict flow through the vein.

Having attached the stabilization device 300 to the extension assembly 360 and having placed the stabilization device 300 in the desired position at or near the insertion site (for example, so that the recess 310 aligns with or lies over the vein in which the i.v. catheter 350 is disposed), the user can secure the stabilization device 300 to the patient. For example, although not shown in FIGS.

14 and 15, in some cases, the user may secure the stabilization device 300 to the patient's target location by means of tape or the like. More particularly, in some cases, a user may secure stabilization device 300 to the patient's target location using two tape strips as described in detail above with reference to stabilization device 200 and FIGS. 8 and 9. Although it is described that the stabilization device 300 is secured to the target location of the patient by means of, for example, two tape strips, it is to be understood that the stabilization device 300 can be secured to the target location of the patient. patient (eg, patient skin at or near an i.v. insertion site) in any suitable manner, such as those described above with reference to stabilization device 200. Accordingly, the procedure of securing stabilization device 300 to the Target location of the patient is not described in more detail herein.

As described above, securing stabilization device 300 to the patient's skin (eg, by means of tape strips 332 and 334) results in stabilization device 300 and/or tape securing, stabilizing, and/or or substantially immobilize the i.v. catheter. 350 with respect to the patient. That is, the arrangement of the stabilization device 300 is such that securing the stabilization device 300 and the i.v. 350 to the patient's skin can substantially reduce and/or prevent movement of the i.v. 350 or at least one i.v. thereof with respect to the vein in which the i.v. catheter is at least partially disposed, as described in more detail herein with respect to a specific embodiment. Furthermore, the arrangement of the recess 310 along the base surface 308 is such that securing and/or adhering the stabilization device 300 to the patient's skin does not exert a force on the vein in which the i.v. catheter is disposed. 350, thereby substantially reducing and/or eliminating any obstruction and/or restriction that would otherwise result from said force.

The FIG. 16 is a flow chart illustrating a method 10 of using a stabilization device according to one embodiment. The stabilization device can have any suitable shape, size and/or configuration. For example, in some embodiments, the stabilization device may be substantially similar to stabilization devices 100, 200, and/or 300 described above. Accordingly, the stabilization device can be used to secure and/or stabilize an at least partially disposed vascular access device (VAD) in a patient. As described above, the VAD may be any suitable device or set of devices. For example, in some embodiments, the VAD may be an iv catheter. In other embodiments, the ^v A ^d may be an adapter or connector (eg, an extension set) attached to an indwelling or placed iv catheter.

As shown in FIG. 16, method 10 includes attaching the stabilization device to the VAD at least partially disposed in a vein of a patient, at 11. As described above with reference to stabilization devices 200 and/or 300, the stabilization device may include an engaging surface (eg, engaging surfaces 212 and/or 312) configured to receive and/or engage a part of the VAD. For example, in some embodiments, the VAD may include and/or may be an i.v. catheter. which attaches to an i.v. extension set. or similar. As described above with reference to stabilization devices 200 and/or 300, the extension set may be a dual-port adapter or extension set having, for example, a T-configuration or the like. In such embodiments, coupling the stabilization device to the VAD may include placing the extension assembly in contact with the stabilization device mating surface such that a side port or the like of the extension assembly aligns with and/or it is in contact with a side channel included and/or formed by the mating surface (see, for example, FIGS. 7, 14 and/or 15).

In some embodiments, the mating surface may include one or more features, protrusions, members, etc. configured to selectively engage a portion of the VAD or adapter if, for example, the stabilization device, VAD, and/or adapter are in an undesired orientation or the like, as described above with reference to engaging surface 312. For example, In some embodiments, attaching the stabilization device to the VAD includes attaching the stabilization device to an extension assembly, aligning a longitudinal axis of the extension assembly with a longitudinal centerline of the stabilization device (eg, such that the longitudinal axis and longitudinal centerline are coaxial, parallel, and/or otherwise extend in a substantially similar direction), and by placing the extension assembly in contact with the mating surface of the stabilization device. As described above, when the stabilization device and/or extension assembly are in a desired orientation and/or are otherwise oriented in the same direction, the extension assembly's side port can be aligned with and brought into contact with a lateral channel of the mating surface. However, if the extension and/or stabilization assembly are not in the desired orientation and/or are oriented otherwise in opposite directions, characteristic features, bumps, limbs, etc. of the mating surface can engage a part of the extension assembly which in turn can result in the extension assembly side port being misaligned with respect to the side channel and thus substantially prevented from coming into contact with it (as described in detail above with reference to the stabilization device 300). In other embodiments, the stabilization device engagement surface need not include such or the like feature.

After the stabilization device is attached to the VAD, the stabilization device is positioned on the patient's skin (eg, at a target location) such that a recessed portion formed by a base surface of the stabilization device aligns with the vein, at 12. As described above with reference to stabilization devices 100, 200, and/or 300, the recessed portion may be configured to substantially reduce and/or prevent the base surface from exerting unwanted force on the vein. of the patient when the stabilization device is secured to the patient's skin. Consequently, the position of the stabilization device with respect to the target location and/or an i.v. it can be adjusted until the recessed portion aligns with and/or lies over or around the vein.

With the stabilization device in the desired position, a first strip of tape is applied to a proximal surface of the stabilization device such that each of a first end portion and a second end portion of the first tape strip are in contact. contact with the patient's target location and are distal to a medial portion of the first tape strip, at 13. As described above with reference to stabilization device 200, the first tape strip may be applied to the stabilization device so that a part of the first strip overlaps and/or adheres to at least a part of the proximal surface of the stabilization device. In some embodiments, the proximal surface of the stabilization device may be of a size and/or shape that is configured to result in flexing or bowing of the first strip of tape when applied to the proximal surface (for example, as described above with reference to FIGS.8 and 9). The bending and/or bowing of the first tape strip, in turn, results in each of the first end portion and second end portion of the tape being secured to the target location of the patient (eg, to the patient's skin at or near the i.v. insertion site) at a position distal to the proximal surface of the stabilization device. In addition, the medial part of the first tape strip (for example, a central part) is at least partially in contact with the proximal surface of the stabilization device and at least partially in contact with the patient's skin at or near the location target (see, for example, FIGS. 8 and 9).

The method 10 includes applying a second tape strip to a portion of the stabilization device such that the second tape strip at least partially overlaps the first end portion and the second end portion of the first tape strip, in 14. For example, as described above with reference to FIGS. 8 and 9, the second tape strip can be applied transversely to the stabilization device part so that a first end portion of the second tape tape adheres to the patient's skin and overlaps at least partially the first one. end part of the first strip of adhesive tape; a second end portion of the second adhesive strip is adhered to the patient's skin and at least partially overlaps the second end portion of the first adhesive strip; and a medial or central portion of the second tape strip is adhered to the stabilization device portion and/or to the extension assembly. Furthermore, the stabilization device portion is distal to the proximal surface to which the first strip of tape is adhered. In some embodiments, placing a portion of the second strip of tape over a portion of the first strip of tape can enhance the adhesion of at least one of the first strip or the second strip. In other words, placing a portion of the second adhesive strip over a portion of the first adhesive strip can reduce a likelihood that the first adhesive strip portion will loosen, disengage, and/or otherwise break the bond. adhesive bond.

In some embodiments, the arrangement of the first tape strip and the second tape strip may be such that a proximal locking mechanism of the extension assembly extends between and/or through a defined gap, gap, and/or gap. between, for example, the medial part of the first tape strip and the medial part of the second tape strip (see, for example, FIGS. 8 and 9). In other words, neither the first nor the second strip of tape obstructs the proximal locking mechanism of the extension set. Accordingly, any suitable device or the like can be coupled to the proximal locking mechanism of the extension set when the stabilization device is secured to the target location of the patient.

As described above, securing the stabilization device to the patient's skin at, on, or near the target location (for example, by means of the tape strips) results in the stabilization device securing, stabilizing, and/or substantially immobilize the IV catheter with respect to the target location of the patient. That is, the arrangement of the stabilization device is such that securing the stabilization device and the iv catheter to the patient's skin can substantially reduce and/or prevent movement of the iv catheter or at least one iv catheter with respect to the vein in which the iv catheter is at least partially disposed, as described in more detail herein with respect to one embodiment specific. In addition, the disposition of the recessed part along the base surface is such that securing and/or adhering the stabilization device to the patient's skin does not exert a force on the vein in which the iv catheter is disposed, reducing and/or thereby substantially removing any resulting obstruction and/or restriction that would otherwise result from said force.

Although various embodiments have been described above, it is to be understood that they have been presented by way of example only, and without limitation. When the diagrams and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components can be modified. Although various embodiments having particular feature features and/or component combinations have been described, other embodiments having a combination of any feature feature and/or component of any of the embodiments are possible as discussed above. Although the embodiments have been shown and described in particular, it will be understood that various changes in shape and detail may be made.

In some embodiments, the specific configurations of the various components can also be varied. For example, the specific size and shape of the various components may be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired rate and/or volume of bodily fluid flow into a fluid reservoir. Also, the size and/or shape of the various components can be specifically selected for a desired or intended use.

When the procedures and/or schemes described above indicate certain events and/or flow patterns that occur in a certain order, the order of certain events and/or flow patterns can be modified. Furthermore, certain events can be performed simultaneously in parallel procedures where possible, as well as sequentially.

Claims (14)

1. An apparatus, comprising: a stabilization device (100) having a distal end portion (106), a proximal end portion (102), and a longitudinal centerline extending between the distal end portion and the proximal end portion, the stabilization device stabilization configured to stabilize an access device when a distal end portion of the access device is inserted through a target location of a patient and disposed at least partially within a part of the patient, including the stabilization device: an engaging surface (112) configured to be placed in contact with an adapter attached to a proximal end portion of the access device, wherein the engaging surface comprises at least one lateral channel extending substantially perpendicular to the longitudinal centerline of the stabilization device, at least one protrusion formed on the engagement surface and extending substantially parallel to the longitudinal center line of the stabilization device, wherein the at least one protrusion is located outside the at least one lateral channel of the engagement surface, a proximal surface (104) forming at least one configured angle to facilitate attachment of the stabilization device to the target location of the patient, and a base surface (108) forming a contoured portion and a recessed portion (110), the contoured portion configured to contact the patient's target location, the recessed portion configured to move away from the patient's target location when the portion contoured is in contact with the target location of the patient, the stabilization device configured to lock to the target location of the patient such that (i) the adapter is held in a fixed position with respect to the mating surface and (ii) the access device is stabilized with respect to the target location of the patient. The apparatus of claim 1, wherein the access device is a vascular access device. The apparatus of claim 1, wherein the access device is an intravenous catheter configured to be disposed at least partially within a vein of a patient. The apparatus of claim 1, wherein the access device is an intravenous catheter configured to be disposed at least partially within a vein of a patient, the stabilization device (100) configured to be positioned with respect to the target location such that (i) the contoured portion of the base surface (108) is in contact with the patient's target location and (ii) the recessed portion (110) of the base surface aligns with and is offset from the vein wherein the intravenous catheter is at least partially disposed. The apparatus of claim 1, wherein the adapter is an extension set and the access device is an intravenous catheter. The apparatus of claim 1, wherein the adapter is a T-adapter having a proximal locking mechanism, a distal locking mechanism, and a side port, the side port being substantially perpendicular to a longitudinal axis of the adapter in T that extends through the proximal locking mechanism and the distal locking mechanism, and The at least one side channel of the mating surface (112) is configured to be placed in contact with the side port of the T-adapter. The apparatus of claim 6, wherein the at least one protrusion is configured to selectively engage the T-adapter such that when the distal locking mechanism of the T-adapter contacts a distal portion of the T-adapter surface coupling (112), the position of the lateral port along the longitudinal axis of the T-adapter aligns with a position of the at least one lateral channel along the longitudinal centerline of the stabilization device (100) to allow the side port is placed in contact with the at least one side channel. The apparatus of claim 6, wherein the at least one protrusion is configured to selectively engage the T-adapter such that when the proximal locking mechanism of the T-adapter contacts a distal portion of the T-adapter surface coupling (112), the position of the port along the longitudinal axis of the T-adapter is misaligned with respect to a position of the at least one lateral channel along the longitudinal centerline of the stabilization device (100) such that contact between the lateral port and the at least one side channel is substantially prevented. The apparatus of claim 1, wherein The mating surface (112) includes a first part and a second part, the first part of the mating surface includes at least one protrusion that extends substantially parallel to the longitudinal centerline of the stabilization device (100) and is configured to selectively engaging the adapter such that (i) one part of the adapter aligns with and is configured to engage the second mating surface part when the first mating surface part contacts an end part adapter portion, and (ii) the adapter portion misaligns with and separates from the second mating surface portion when the first mating surface portion contacts a proximal end portion of the adapter, in the that the second part of the mating surface comprises at least one lateral channel extending substantially perpendicular to the ce line longitudinal center of the stabilization device, and furthermore wherein the at least one protuberance is located outside the at least one lateral channel of the engaging surface. The apparatus of claim 1, wherein the contoured portion of the base surface (108) is configured to contact the target location of the patient and to apply a force to the target location when the stabilization device ( 100) is secured to the target location, the recessed portion (110) of the base surface is configured to align with and offset from the vein in which the IV catheter is disposed at least partially so that force is not applied to the vein. vein at the target location when the stabilization device is secured at the target location. The apparatus of claim 10, wherein the first mating surface portion (112) defines a notch configured to receive an adapter portion. The apparatus of claim 10, wherein the first engaging surface portion (112) is a distal engaging surface portion. The apparatus of claim 12, the adapter is a T-adapter, the proximal end portion of the T-adapter including a proximal locking mechanism and the distal end portion of the T-adapter including a distal locking mechanism, the part of the adapter is a side port of the T-adapter, the side port being substantially perpendicular to a longitudinal axis of the T-adapter that extends through the proximal locking mechanism and the distal locking mechanism. The apparatus of claim 13, wherein a position of the side port along the longitudinal axis of the T-adapter (i) substantially aligns with a position of the at least one side channel along the longitudinal center line. of the stabilization device (100) when the distal locking mechanism is in contact with the distal part of the mating surface, and (ii) is misaligned with respect to a position of the at least one side channel along the center line length of the stabilization device when the proximal locking mechanism is in contact with the distal part of the mating surface (112).